SOURCE: Recordati S.p.A.

December 21, 2006 10:12 ET

RECORDATI signs co-marketing agreement with SIGMA-TAU in Italy for its new antihypertension product

MILAN, ITALY -- (MARKET WIRE) -- December 21, 2006 -- Recordati announced that it has signed a non-exclusive agreement with sigma-tau, a leading Italian pharmaceutical company, for the marketing and sale in Italy of its new antihypertensive drug which combines lercanidipine and enalapril. The launch is expected to take place at the beginning of 2008 following approval in 2007. The new specialty, a fixed combination of lercanidipine and enalapril, was approved in Germany as announced on 27 July last. Germany will act as Reference Member State in the mutual recognition process for the rest of Europe which is expected to be completed during 2007.

Agreements have already been finalized with other partners in France, Spain, Benelux, the Nordic countries including Finland, Korea, Australia, Taiwan, the Middle East including Israel, and South Africa. Further agreements are near completion.

Most hypertensive patients, especially those with other associated risk factors, now require multiple therapies using more than one drug to keep their blood pressure at desired levels. Fixed combinations of more than one antihypertensive agent will therefore play a significant and increasing role in the future hypertension market. The advantages of fixed combinations as opposed to the administration of separate treatments are significant. The combined dosages of the drugs are those broadly used by the physician and their efficacy and tolerability have been proven in clinical trials. The reduction of the number of pills a patient must take, especially in the elderly, increases patient compliance - which is extremely important in chronic treatments aimed at reducing and preventing cardiovascular risk.

"We are delighted to have sigma-tau as co-marketer in Italy for our new drug", stated Giovanni Recordati, Chairman and CEO. "I am confident that sigma-tau, one of the leading pharmaceutical companies in Italy, will contribute effectively to extend the use of this new therapeutic option for the treatment of hypertension."

Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), dedicated to the research, development, manufacturing and marketing of pharmaceuticals, with headquarters in Milan, Italy, operations in the main European countries, and a total staff of over 2,000. A European field force of over 1,000 medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas. Recordati's current and growing coverage of the European pharmaceutical market makes it a partner of choice for new product licenses from companies which do not have European marketing organizations. Recordati is committed to the research of new drug entities within the cardiovascular and urogenital therapeutic areas in which its research team has proven scientific competence and a track record of discovery and development of original drugs, the most recent of which, lercanidipine, a latest generation calcium channel blocker for the treatment of hypertension, is the company's leading product. Consolidated revenue for 2005 was EUR 576.1 million, operating income was EUR 111.1 million and net income was EUR 64.5 million.

sigma-tau was founded at the end of the 1950's and is the second largest Italian pharmaceutical group. It employs 2,400 people, 400 of whom work in R&D. Since its creation, the Group has made significant investments in R&D activities. The Group focuses on the following therapeutic areas: cardiovascular, metabolism, central and peripheral nervous system, immunology and oncology. Particular significance in the latter area has "Gimatecan", a novel oral anticancer compound. A major agreement was signed in 2003 with the Swiss multinational drug company Novartis, which acquired the worldwide development and marketing rights for Gimatecan from sigma-tau. Currently, sigma-tau's portfolio includes 48 projects in several therapeutic areas; clinical trials are being conducted in 32 different indications; 16 proprietary molecules are under investigation, 13 of which are NCEs (New Chemical Entities). sigma-tau is particularly proud of its R&D efforts in the area of "Rare Diseases" which is being intensively developed by its US subsidiary, sigma-tau Pharmaceuticals, Inc.. The Group, headquartered in Pomezia (Rome), has subsidiaries in France, Switzerland, the Netherlands, Portugal, Germany, the USA (Gaithersburg, Maryland), as well as in Spain and Sudan, where the Group runs two production facilities. Finally, sigma-tau has recently established cooperations in China for the worldwide development of an anti-malarial drug deriving from Chinese Traditional Medicine.

Statements contained in this release, other than historical facts, are "forward-looking statements" (as such term is defined in the Private Securities Litigation Reform Act of 1995). These statements are based on currently available information, on current best estimates, and on assumptions believed to be reasonable. This information, these estimates and assumptions may prove to be incomplete or erroneous, and involve numerous risks and uncertainties, beyond the Company's control. Hence, actual results may differ materially from those expressed or implied by such forward-looking statements.

All mentions and descriptions of Recordati products are intended solely as information on the general nature of the company's activities and are not intended to indicate the advisability of administering any product in any particular instance.

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